Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT06307704
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2024-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lung US for PEEP Optimization in Robotic Radical Prostatectomy or Cystectomy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2024-03-06', 'studyFirstSubmitQcDate': '2024-03-11', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative lung consolidation', 'timeFrame': '24 hours', 'description': 'Presence (or not) of post-operative lung consolidation detected by lung ultrasound.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radical Cystectomy', 'Radical Prostatectomy', 'Robotic', 'Anesthesia', 'Lung-Ultrasound', 'Positive End Expiratory Pressure'], 'conditions': ['Prostate Cancer', 'Urinary Bladder Cancer', 'Surgery', 'Positive End Expiratory Pressure', 'Lung Ultrasound']}, 'descriptionModule': {'briefSummary': 'There is an increasing trend in the use of robotic-assisted radical prostatectomy or cystectomy (RARPC).\n\nPreventing lung atelectasis without inducing overdistention of the lung is challenging. Many studies tried to optimize PEEP titration by using methods such as dead space fraction guided and static pulmonary compliance directed techniques, or by using electrical impedance tomography. However, the use of these methods is limited by inaccuracy and the need for sophisticated devices.\n\nBedside Lung ultrasound is fast, easy and economic technique that is gaining interest in the operating room. Ultrasound-guided PEEP titration has been used in bariatric surgeries (different position and usually shorter procedure time) and proved effective in improving oxygenation, compliance and reducing the incidence of postoperative pulmonary atelectasis and hypoxia without causing hemodynamic instability.\n\nThe aim of this study is to evaluate the effectiveness of intraoperative individualized lung ultrasound-guided stepwise PEEP optimization in patients undergoing RARPC on oxygenation, intraoperative and early postoperative pulmonary complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I, II \\& III.\n* Normal respiratory functions or mild lung disease.\n\nExclusion Criteria:\n\n* BMI more than 40.\n* Moderate to severe obstructive pulmonary disease (FEV1 \\< 80% of predicted).\n* Moderate to severe restrictive pulmonary disease (TLC \\< 70% of predicted).\n* Severe pulmonary hypertension (mean PAP\\>55).\n* Previous lung surgery.\n* Decompensated cardiac disease (NYHA 3 or 4).\n* Patients who received invasive mechanical ventilation within the last 30 days before surgery.'}, 'identificationModule': {'nctId': 'NCT06307704', 'briefTitle': 'Lung US for PEEP Optimization in Robotic Radical Prostatectomy or Cystectomy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Intraoperative Bedside Lung-ultrasound Use to Optimize Positive End-expiratory Pressure for Elective Robotic-assisted Radical Prostatectomy or Cystectomy Patients: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LUSPEEPORRPC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'US - PEEP group', 'description': 'Lung Ultrasound - guided Positive End Expiratory Pressure group', 'interventionNames': ['Procedure: Lung Ultrasound - guided Stepwise PEEP', 'Procedure: Standard Ventilation Protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard group', 'description': 'Standard Ventilation group', 'interventionNames': ['Procedure: Standard Ventilation Protocol']}], 'interventions': [{'name': 'Lung Ultrasound - guided Stepwise PEEP', 'type': 'PROCEDURE', 'description': 'After endo-tracheal intubation; A PEEP of 4 cmH2O will be initially used till 5 min after pneumoperitoneum. Then The PEEP will be adjusted in a stepwise approach after performing bedside lung ultrasound. The PEEP will be increased by 2 cmH2O until no lung collapse is detected. Lung ultrasound will be repeated 5 min after every change in the PEEP with a maximal PEEP of 12 cmH2O.', 'armGroupLabels': ['US - PEEP group']}, {'name': 'Standard Ventilation Protocol', 'type': 'PROCEDURE', 'description': 'Volume-controlled ventilation (VCV) mode; with a tidal volume of 6 mL/kg of ideal weight, inspiratory : expiratory ratio 1: 2, PEEP 4 cmH2O, respiratory rate adjusted to keep end-tidal carbon dioxide tension (EtCO2) between 35 and 40 mm Hg, and inspired oxygen fraction of 50%.', 'armGroupLabels': ['Standard group', 'US - PEEP group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mustafa E Mohamed, MD', 'role': 'CONTACT', 'email': 'mustafaemam931@gmail.com', 'phone': '01140806330', 'phoneExt': '+2'}, {'name': 'Nazmy S Mikhael, MD', 'role': 'CONTACT', 'email': 'nazmy.edwar.seif@gmail.com', 'phone': '01227400808', 'phoneExt': '+2'}], 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mustafa E Mohamed, MD', 'role': 'CONTACT', 'email': 'mustafaemam931@gmail.com', 'phone': '01140806330', 'phoneExt': '+2'}, {'name': 'Nazmy S Mikhael, MD', 'role': 'CONTACT', 'email': 'nazmy.edwar.seif@gmail.com', 'phone': '01227400808', 'phoneExt': '+2'}], 'overallOfficials': [{'name': 'Ashgan R Ali, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University'}, {'name': 'Nazmy S Mikhael, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University'}, {'name': 'Mustafa E Mohamed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nazmy Edward Seif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Nazmy Edward Seif', 'investigatorAffiliation': 'Cairo University'}}}}